Process Analytical Technology
The Lighthouse Probe® can be used for real-time monitoring of chemical and pharmaceutical processes and provides in-process window cleaning at any time, recalibration during the process, full CIP of wash housing and seal, and a clear view inside – even in difficult conditions.
The biggest flaw of optical spectroscopy is the dependency on a clean observation window. When window fouling occurs during process, it will eventually lead to wrong analysis results, unwanted process stops and bad product quality. Since on-line and in-line optical analysis becomes more and more important, reliable and robust systems capable of overcoming this flaw, are needed.
Though various vendors made attempts to overcome the issue using window heating and blow off systems, none of these ‘solutions’ seemed to work over longer time span. And all of them had the same flaw: once the fouling occurred, there was no way of recovering. To ensure an optical detection that can overcome these issues and check its status during the process, the Lighthouse Probe® was developed. The probe has window cleaning capabilities and an internal reference to overcome a second frequently encountered issue namely reference contamination. Both these functions can be used in process without breaking containment.
The Lighthouse Probe® comes in 2 different types:
The probes can be upgraded from manual to automated CIP alongside with the development of your product from laboratory to production. They can be delivered matching a variety of spectrometers.
Example:
During the FAT of a Consigma® tableting line, the Lighthouse Probe® was used for on-line moisture analysis: The moisture of the final granulate was available in real time while off-line lab analysis took one week to analyze only one third of the samples (time savings).
The difference in resources savings consumption during that same FAT was 2 man-week of lab analysis (and lab-consumables).
Because of the direct availability of the analyzer data, deviation from the desired quality is detected immediately and corrections were made based on that data and the process moved back to optimal quality before even going out of spec. The offline analysis of one sample took 12 minutes (optimal case) so the minimal waste in case of a bad result in case of off-line analysis is 5 kg (throughput of the machine being 25kg/hr) (material savings)
The Lighthouse Probe® provides:
Online Process Monitoring
For initial test work or for mobile test equipment, a manual probe is suggested while automated wash and CIP probes are designed for production.
For single pot processing including drying, a CIP probe is advised combined with a complete integration to change models between granulation and drying regime.
The LightHouse Probe® fits on a standard 2” port, standard adaptor or weld-in ports can be provided. It is available as manual probe, automated wash probe and automated CIP probe.
Genzyme reduces probe fouling and improves NIR data using the Lighthouse Probe®.
In 2011, Genzyme, at the time one of the world’s leading biotechnology companies, was looking for a PAT solution to control the high shear granulation of a development product by measuring a critical product attribute, rather than relying purely on time based processing or impeller current loading. The company used an optimized Lighthouse Probe® to get representative NIR data of a granulation process. Read the article to learn how the data was then correlated to moisture content, bulk/tapped density and particle size of the final product.
The ConsiGma® GD 25/80 offers standalone continuous twin-screw granulation and drying for small-scale R&D operations. It allows users to develop the process and achieve high granule quality on a compact unit.
A highly integrated solution for continuous linear blending and direct compression, the ConsiGma® DC-LB lines offer all the advantages of continuous manufacturing: supply chain agility, small footprint, controlled blending and compression and improved quality.
Highly integrated solutions for continuous wet granulation, drying and tablet compression, the ConsiGma® GC lines offer all the advantages of continuous manufacturing: supply chain agility, small footprint, controlled granulation and improved quality.
UltimaPro Single Pot Processors (One-Pot Processor) offer a choice of mixing, granulation and drying options integrated into one processing vessel. With our help, choose the most appropriate technique for the product.
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